Inspiring Innovation in Formulation, Bioprocessing and Drug Delivery

Hot Topic: AI/ML + FDA: Best Practices, Themes & Considerations for Regulatory Success in Drugs, Diagnostics, & Devices

Hot Topic Moderator(s)

• 

  Rikhav Gala, PhD, M.Sc.

  Sr. Principal Scientist and Group Lead
  Pfizer INC
  Lowell, Massachusetts

Presentations:

• 3:00 PM - 3:10 PM ET

  Evolving Role of AI/ML in Drug Development
  

  Hot Topic Speaker: Eric Luellen, Msc, MPH (he/him/his) – Turing Biosciences LLC
• 3:10 PM - 3:30 PM ET

  Regulatory Expectations and Best Practices in FDA Engagement for AI/ML Products
  

  Hot Topic Speaker: Alex Cadotte, PhD – MCRA, and IQVIA company
• 3:30 PM - 4:00 PM ET

  Future Directions: Harmonizing Innovation with Regulation – Panel Discussion
  

  Hot Topic Moderator: Rikhav P. Gala, PhD, M.Sc. – Pfizer INC

  Hot Topic Speaker: Eric Luellen, Msc, MPH (he/him/his) – Turing Biosciences LLC

  Hot Topic Speaker: Alex Cadotte, PhD – MCRA, and IQVIA company